About the Role
Are you a problem-solver with a passion for collaboration? Do you want to make a difference in the fight against infectious diseases? We’re seeking individuals who thrive in a supportive, team-oriented environment and are committed to delivering impactful solutions in the field of diagnostics. Your ideas, contributions, and achievements will be valued and celebrated here.
About the Company
We specialize in the development and production of diagnostic tools for emerging infectious diseases and bio-threats. Established in the mid-'90s, we are committed to creating high-quality, user-friendly, and cost-effective products. Our extensive portfolio includes over 25 diagnostic products and a wide range of life science reagents. Our main office is located in a vibrant neighborhood known for its biotech innovations, with a secondary location in a historic area near a major sports venue. We offer competitive salaries, a comprehensive benefits package including health insurance, retirement plans, and performance-based bonuses, as well as a commitment to work-life balance, which includes generous paid time off and an end-of-year shutdown.
About You
We’re looking for a detail-oriented professional with substantial experience in regulatory affairs, particularly concerning in-vitro diagnostic (IVD) products. A deep understanding of immunoassays and molecular assays, along with familiarity with FDA and international regulations, is essential. Your ability to stay updated with evolving regulatory landscapes, manage multiple projects, and work closely with regulatory bodies is key to this role. If you enjoy leading and contributing to projects, and have a strong background in regulatory submissions, we encourage you to apply.
Key Qualifications:
- Bachelor’s or Master’s degree in life sciences or bioengineering, with at least 5 years of experience in an FDA-regulated IVD environment, or a Ph.D. with 2 years of relevant experience.
- Preferred certification in regulatory affairs.
- In-depth knowledge of US and international IVD regulations.
- Strong communication skills, both written and verbal.
- High attention to detail and excellent organizational skills.
- Proficiency with technical systems (e.g., MS Office, statistical tools, online research).
- Experience with regulatory submissions (EUA, 510(k), De Novo, PMA) for lateral flow and PCR assays.
- Ability to identify and manage compliance risks.
Primary Responsibilities:
- Represent and lead Regulatory Affairs in product life cycle teams.
- Draft and review protocols for analytical studies supporting regulatory submissions.
- Assist with the preparation and submission of regulatory documents such as EUAs and 510(k)s.
- Support international product registrations, maintain technical files, and prepare product dossiers.
- Lead Risk Management initiatives and ensure regulatory compliance in labeling and marketing materials.
- Set regulatory strategies for new product development.
- Stay informed about the latest regulatory trends and requirements.
- Communicate with regulatory authorities, including the FDA, regarding product submissions.
Work Environment
This position requires on-site work, primarily in an office setting with long periods at a computer. Some tasks involve working in a BSL-2 laboratory and controlled environments.
Compensation and Benefits
- Annual Salary: $90,000 - $125,000
- Comprehensive benefits including medical, dental, vision, life insurance, and long-term disability coverage.
- Enrollment in retirement savings plans (401k/Roth IRA) and Flexible Savings Accounts (FSA).
- Paid vacation: 2 weeks annually, plus 11 paid holidays, including a winter break at the end of the year.
